Search Results for “EC” – Page 278 – media

Henlius Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Serplulimab in ES-SCLC

Recently, an Innovation Passport designation has been awarded to serplulimab, Henlius’ self-developed anti-PD-1 mAb (trade name in China: HANSIZHUANG), for the treatment of extensive stage small cell lung cancer (ES-SCLC) by the U.K. Innovative Licensing and Access Pathway Steering Group including the Medicines & Healthcare products Regulatory Agency (MHRA). This designation marks serplulimab’s entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) and is expected to promote the presence of serplulimab in the U.K., benefiting more local SCLC patients. ILAP steering group consists of The All Wales Therapeutics and Toxicology Centre (AWTTC), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). It was launched by the MHRA in order to accelerate the development and access to promising medicines. The designation is open to medicinal product that developed for life-threatening or seriously debilitating condition and meet ...
- Source: drugdu
- 107
- March 18, 2024
SHANGHAI RAAS and Boehringer Ingelheim enter into a major collaboration to develop innovative drugs for hemophilia

SHANGHAI RAAS and Boehringer Ingelheim, one of the world’s leading biopharmaceutical companies, announced today that they have entered into a major collaboration: Boehringer Ingelheim BioPharmaceuticals (China) Ltd. will provide process transfer and clinical manufacturing services for SHANGHAI RAAS’s innovative hemophilia drug, SR604 injection. Boehringer Ingelheim China Biopharmaceutical (“Boehringer Ingelheim China Biopharmaceutical”) will provide process transfer and clinical manufacturing services for SR604 injection, an innovative hemophilia drug under Shanghai Lacey, which will be transformed into a high-quality end-product through the international first-class CDMO platform, helping Chinese innovations to go overseas to benefit patients worldwide. SR604 injection is a humanized monoclonal antibody that binds human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. Recently, the State Drug Administration (SDA) has officially approved SR604 injection. Recently, the State Drug Administration formally approved an application for a clinical phase I trial of SR604 injection, to ...
- Source: drugdu
- 117
- March 18, 2024
Rapid Test Diagnoses Tropical Disease within Hours for Faster Antibiotics Treatment

Melioidosis, a neglected tropical disease, is believed to affect around 165,000 individuals globally each year, with approximately 89,000 succumbing to it. This illness is caused by the bacterium Burkholderia pseudomallei, which thrives in the soil and water of tropical and subtropical areas, gaining entry into humans through skin cuts, consumption, or inhalation. Diagnosing melioidosis poses challenges due to its varying symptoms ranging from localized infections and pneumonia to severe septicemia or prolonged chronic conditions. The disease’s tendency to predominantly affect isolated rural communities contributes to its significant underreporting. Diagnosis traditionally depends on culturing bacterial specimens, a process extending over three to four days. Meanwhile, a large percentage of patients with melioidosis succumb to the disease, often within the initial 24 to 48 hours of hospital admission, while waiting for a diagnosis. Although no vaccine exists for melioidosis, it can be effectively managed with specific intravenous antibiotics if identified promptly. However, ...
- Source: drugdu
- 83
- March 16, 2024
Schizophrenia Trial Failure Ends Acadia’s Efforts to Expand Use of Its Flagship Drug

With pimavanserin’s Phase 3 failure in schizophrenia, Acadia Pharmaceuticals said it will no longer run clinical trials for the drug, whose lone approval is for treating psychosis from Parkinson’s disease. The FDA previously rebuffed regulatory submissions for the drug in dementia and Alzheimer’s disease. By FRANK VINLUAN An Acadia Pharmaceuticals drug that’s already approved for treating psychosis in Parkinson’s disease patients could not beat a placebo in a pivotal schizophrenia study, spelling the end of efforts to develop a medication the company once envisioned as having potential applications across a range of neurological disorders. The clinical trial failure announced Tuesday evaluated the drug, pimavanserin, as a treatment for negative symptoms of schizophrenia. The main goal was to show a change in score according to an assessment used to measure the disease’s symptoms. According to the preliminary results, the pimavanserin arm achieved a numerical change in score that was similar to ...
- Source: drugdu
- 146
- March 16, 2024
Scientists develop micofluidic chip to make cell therapy safer

The chip removes cells, which could become tumours, before they are implanted in a patient Researchers from the Massachusetts Institute of Technology (MIT) and the Singapore-MIT Alliance for Research and Technology have developed a plastic microfluidic chip to improve the safety and effectiveness of cell therapy treatments for patients living with spinal cord injuries. In cell therapy, clinicians create induced pluripotent stem cells using skin or blood cells from a patient. When treating a spinal cord injury, pluripotent stem cells are transformed into progenitor cells, which differentiate into spinal cord cells, which are transplanted back into the patient. Despite being able to regenerate part of the injured spinal cord, pluripotent stem cells do not completely change into progenitors and can form tumours. Researchers developed a microfluidic cell sorter to remove around half of the undifferentiated cells in a batch to mitigate potential tumours without causing damage to fully-formed progenitor cells. ...
- Source: drugdu
- 145
- March 16, 2024
Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients

The platform delivers digitalised patient data to improve clinical trials and development Phesi has announced that its artificial intelligence (AI)-driven Trial Accelerator platform has reached a critical milestone of now containing global data from more than 100 million patients. The volume will allow sponsors to access data on patients with over 4,000 indications, plan more successful trials and simulate clinical development activity more accurately. Phesi’s Trial Accelerator works to deliver digitalised patient data to enhance or replace those collected from clinical trials. Across the past two decades, data has been collated from product and disease registries, electronic health records, medical claims data and data gathered from around 100,000 dynamically updated sources. The platform powers the Phesi Patient Access Score, Diversity, Equity and Inclusion Data Service and the Digital Patient Profile. “We have been gathering and structuring a wealth of data for sponsors and clinical trial planners,” said Dr Gen Li, ...
- Source: drugdu
- 97
- March 16, 2024
Royal Marsden to implement RaySearch’s online adaptive radiation therapy system

OART is increasingly emerging to assess and adapt treatment for cancer patients The Royal Marsden NHS Foundation Trust is set to implement online adaptive radiation therapy (OART) with RaySearch’s treatment planning system, RayStation, and oncology information system, RayCare. OART is a novel treatment for cancer patients that is increasingly emerging to assess patients’ anatomy, with a treatment plan adapted from an original reference plan with the patient on the treatment couch. The Royal Marsden has been using RayStation for conventional treatment planning since 2016 and most recently acquired two additional Radixact treatment delivery machines from Accuray to be used for OART. Daily-acquired patient images are used by OART to optimise treatment plans by considering the changes in the patients’ anatomy. OART puts high demand on the acquired images and an efficient information flow between the treatment planning system, the oncology information system and the treatment control system. RaySearch and Accuray’s ...
- Source: drugdu
- 104
- March 16, 2024
Roche partners with Cardiff researchers to uncover new research into dementia

Affecting 55 million people globally, dementia impairs the ability to remember, think or make decisionsRoche and the Cardiff University Brain Research Imaging Centre (CUBRIC) have partnered to uncover new research to understand the structural changes of dementia. Using cutting-edge imaging and machine learning (ML), researchers will analyse the brains of patients living with Parkinson’s disease (PD) and Alzheimer’s disease (AD). Dementia is a general term used for the impaired ability to remember, think or make decisions that interferes with day-to-day activities and affects 55 million people globally, according to Alzheimer’s Society. Currently the most common form of dementia, AD is a progressive neurological disease that affects the part of the brain that controls thought, memory and language. PD is a progressive neurodegenerative disorder that affects the body’s nervous system. The main symptoms include shaking, slow movements and stiffness. The study will use advanced MRI to understand the bigger structural changes ...
- Source: drugdu
- 115
- March 16, 2024
AbbVie’s Produodopa approved by SMC to treat Parkinson’s disease patients in Scotland

The progressive neurological disorder affects approximately 12,400 people in Scotland AbbVie’s Produodopa (foslevodopa-foscarbidopa) has been accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland to treat advanced levodopa-responsive Parkinson’s disease (PD). PD patients with severe motor fluctuations and hyperkinesia or dyskinesia when previous available combinations of PD medicinal products have not provided satisfactory results and who are not eligible for deep brain stimulation will be eligible for the treatment. Affecting around 12,400 people in Scotland, PD is a progressive neurological disorder that results from the loss of dopamine-producing brain cells and is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance. Patients with advanced PD are marked by more severe and complex symptoms, including severe motor deficits, a risk of falling and cognitive problems. The SMC’s decision is supported by data from two phase 3 clinical trials, M15-741 and M15-736, which demonstrated that Produodopa ...
- Source: drugdu
- 151
- March 15, 2024
US study reveals age-related skin changes could contribute to melanoma metastases

Around 200,000 people in the US are expected to be diagnosed with the skin cancer this year Researchers from the Johns Hopkins Kimmel Cancer Center have revealed that age-related changes in the skin could also contribute to higher rates of melanoma metastases, a form of skin cancer, in older people. Recognised as the deadliest form of skin cancer, according to the Melanoma Research Foundation, melanoma is often caused by too much sun exposure. In 2024, it is estimated that 200,000 people in the US will be diagnosed with the condition. Published in Nature Aging, the study showed that increased stiffness in ageing skin increases the release of ICAM1, a protein that regulates endothelial and epithelial barrier function, stimulating blood vessel growth in the tumour and promoting its growth. Researchers treated older mice with melanoma with drugs that block ICAM1 by reducing a gene known as HAPLN1, which indirectly increases ICAM1 ...
- Source: drugdu
- 145
- March 15, 2024

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